TGA to Migrate Clinical Trial Applications to New Online System
Posted 14 October 2015 | By
The Therapeutic Goods Administration (TGA) will begin migrating clinical trial forms from a paper-based system to a new online system later this month.
To conduct a clinical trial in Australia on an unapproved product, or for an unapproved use of a product, a company must either submit a clinical trial notification (CTN) or a Clinical Trial Exemption (CTX).
The vast majority of clinical trials conducted in Australia follow the CTN scheme, which requires the company to submit its trial plans to a human research ethics committee (HREC) for review before getting final sign off from the site where the trial will be conducted.
Under the more rigorous CTX scheme, a company must also receive approval from TGA before beginning a trial.
Online CTN Forms
In July, TGA announced the launch of a new online form for CTNs as part of an effort to "improve and streamline" the agency's administrative responsibilities for clinical trials.
In its announcement, TGA touted the benefits of moving to an online system for CTNs:
- reduced administrative burden of managing a paper based system
- online Sponsor declaration replaces requirement for obtaining and submitting original signatures for Principle Investigator, Approval Authority and Human Research Ethics Committee
- manage and track your notifications via your personalised online dashboard
- ability to directly amend/vary information which have been submitted via the new online format
- online invoice generation and payment.
The agency also said the new online system "uses the same functionality of other TGA online applications," so many users would already be familiar with the interface.
To prepare for the upcoming migration, TGA released a "transition" form for companies to notify TGA of changes to their clinical trials for CTNs submitted before 1 July 2015.
As part of the transition, TGA will be converting the paper-based CTNs it received prior to 1 July 2015 to be compatible with the new online system.
The agency says it will close its internal paper-based database on 19 October 2015 to begin work on digitizing the CTNs. Once it finishes reformatting the pre-1 July 2015 CTNs, TGA says it will begin posting the CTN data to the online system.
After the CTNs are all migrated to the online system, TGA says that sponsors "may need to update data for new fields … for example email addresses, information about a medicine's presentation or medical device details that were previously captured in free-text fields."